Allogeneic tumor cell bank

MOLOGEN AG uses a self-established tumor cell bank as the basis for its cell-based genetic therapy against cancer. This cell bank has been created from tumor material provided by a patient with renal cancer and has been established and characterized under specifications compliant with drug law.

The renal cancer cells in the tumor cell bank have certain similarities in their superficial characteristics (known as tumor-associated antigens) to other renal cancer cells and even to cancer cells from completely different tumors, such as breast cancer. They provide an excellent template for showing the immune system of cancer patients what cancer cells typically look like. Since they are alien (allogeneic) to the patient, the immune system recognizes them and an immune reaction is triggered against the surface characteristics of these allogeneic cancer cells. In view of the similarities between the tumor-associated antigens of allogeneic cancer cells and the patient's own cancer cells, the immune system now also recognizes the body's own cancer cells and can override the tolerance toward the cancer. The immune system is therefore once again able to fight the cancer itself.

In order to amplify this effect, the cancer cells are genetically modified before administration by using MIDGE® vectors and combined with the immunomodulator dSLIM® as an enhancing agent. The treatment is also known as cell-based gene therapy and the principle of action known as therapeutic vaccination.

The tumor cell bank was initially being used by MOLOGEN AG for the clinical development of a renal cancer therapy. The development of this product candidate was being conducted under the project name MGN1601. The phase I/II clinical study completed in August 2013 showed excellent tolerability and very positive efficacy data so far. Based on the positive results from this study, the clinical development of MGN1601 could advance to the next phase, which could take the form of a combination study. However under the "Next Level" strategy, further development of this compound has been shelved for the time being, but could be continued again in the event of the successful out-licensing of lefitolimod. MGN1601 would therefore be an attractive next generation clinical product.